Intermittent vs Alternate Daily Regimen of Prednisolone in Ambulatory Boys With Duchenne Muscular Dystrophy

Sponsor
Muhammad Aamir Latif
Study ID
NCT07787689
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
MALE
Age
4 Years - 10 Years
Healthy Volunteers
Not accepted

Interventions

  • Alternate-day prednisolone — DRUG
    Patients will be given alternate-day administration of prednisolone at a dose of 0.75 mg/kg/day.
  • Intermittent prednisolone — DRUG
    Patients will be administered prednisolone at a dose of 0.75 mg/kg/day for 10 consecutive days, followed by a 10-day steroid-free period.

Study Details

The alternate-day regimen is hypothesized to reduce hypothalamic-pituitary-adrenal (HPA) axis suppression and decrease steroid-related toxicity. Similarly, intermittent regimens aim to provide periodic steroid exposure sufficient for muscle preservation while allowing recovery periods to limit side effects. There is a critical need for localized, prospective data to determine which protocol offers the optimal balance of efficacy and safety for pediatric patients in Pakistan.

Key Dates

First listed
Aug 26, 2026
Start date
Sep 15, 2026
Status verified
Aug 2026
Primary completion
Mar 15, 2027
Completion
Mar 15, 2027

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Alternate-Day Prednisolone-Group
    Patients will be given alternate-day administration of prednisolone at a dose of 0.75 mg/kg/day.
  • Experimental: Intermittent Prednisolone-Group
    Patients will be administered prednisolone at a dose of 0.75 mg/kg/day for 10 consecutive days, followed by a 10-day steroid-free period.

Primary Outcome Measure

Treatment efficacy [ Time Frame: 6 month after start of treatment ]

Central Contacts

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Duchenne muscular dystrophy trialsPediatrics trials

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